Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Supervised Exercise Program and Continuous Fitbit Monitoring

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? FitBit+Quality-of-Life Assessment+Questionnaire Administration
Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral, Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response to treatment (refractory) and are receiving androgen deprivation therapy. Balancing treatment efficacy, drug side effects, and competing comorbidities with prostate cancer is essential. This trial is being done to learn if an exercise program can help to improve metabolic syndrome and cardiovascular (heart) fitness in prostate cancer patients who are receiving androgen deprivation therapy.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Willing and able to provide written informed consent

• Histologically or cytologically confirmed adenocarcinoma of the prostate

• Presence of metastatic disease documented on imaging studies (bone scan, computed tomography \[CT\] and/or magnetic resonance imaging \[MRI\]) or biochemical recurrence/refractoriness following local therapy (prostatectomy or radiation)

• Stable or improving disease activity as demonstrated by stable or improving PSA over at least 2 months

• On gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or status post-surgical castration for at least 3 months

• Combination ADT with abiraterone or enzalutamide is permitted

• Anticipation to remain hypogonadal for at least 6 months subsequently

• Asymptomatic bone metastasis is permissible (exercise will be modified and patients monitored)

• Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2

• Patients must be able to finish a maximal exercise stress test which will be assessed by cardiopulmonary exercise testing using a standardized protocol \^70 supervised by a cardiologist

• Hemoglobin \>= 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to enrollment

• Platelet count \>=75,000/uL independent of transfusion and/or growth factors within 3 months prior to enrollment

• Access to a smart phone with android or iPhone OS (iOS) operating systems

• Able to speak and comprehend English

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Christopher J Logothetis
clogothe@mdanderson.org
7135637210
Time Frame
Start Date: 2020-03-23
Estimated Completion Date: 2027-02-02
Participants
Target number of participants: 200
Treatments
Active_comparator: Group I (education exercise packet, FitBit)
Patients receive general education exercise packet with instruction to exercise regularly for up to 150 minutes weekly. Patients also wear a FitBit daily over 16 weeks.
Experimental: Group II (exercise program FitBit)
Patients participate in supervised and self-directed exercise sessions over 60 minutes BIW for up to 16 weeks. Patients also wear a FitBit daily over 16 weeks.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov